Everest Medicines Begins Dosing in China for Global Phase 2b Trial of Zetomipzomib

Everest Medicines Begins Dosing in China for Global Phase 2b Trial of Zetomipzomib

By, Admin 23 July 2024

Everest Medicines Begins Dosing in China for Global Phase 2b Trial of Zetomipzomib for Lupus Nephritis

Overview

Everest Medicines (HKEX 1952.HK) has announced the dosing of the first Chinese patient with zetomipzomib in the global Phase 2b PALIZADE trial targeting active lupus nephritis (LN). Zetomipzomib is an innovative, first-in-class selective immunoproteasome inhibitor, showing promise for treating various autoimmune diseases.

Words from Everest Medicines

  • Everest Medicines, remarked, “This achievement follows the approval of our investigational new drug (IND) application by China’s National Medical Products Administration (NMPA) in February. LN is a prevalent secondary immune-mediated kidney condition that can progressively cause kidney failure. With an estimated 400,000 to 600,000 LN patients in China, there is a significant need for new treatment options.” 
  • He added, “Utilizing our expertise in clinical development, regulatory processes, and commercialization, we aim to expedite the availability of zetomipzomib for Chinese patients. Renal and autoimmune diseases are key areas for Everest, and we currently have three nephrology drugs in development or on the market. We will continue to advance our pipeline to strengthen our position in these fields in Asia.”

Lupus Nephritis in China

  • In China, LN has a high 10-year renal survival rate of 81% to 98%, yet it remains a common cause of end-stage renal disease (ESRD) and contributes significantly to mortality in systemic lupus erythematosus (SLE) patients. 
  • Although there have been advances in LN treatment, including new immunosuppressive and multi-targeted therapies, the flare rate remains high (33% to 40%), leading to chronic kidney damage and progression to ESRD. 
  • Moreover, treatment complications like infections, diabetes, femoral head necrosis, and ovarian failure also affect patient quality of life.

PALIZADE Trial

  • Everest has teamed up with Kezar Life Sciences (“Kezar”) for the PALIZADE trial, a global, placebo-controlled Phase 2b study that evaluates the effectiveness and safety of two dose levels of zetomipzomib in patients with active LN. 
  • Initiated in mid-2023, the trial will enroll 279 patients, who will be randomly assigned to receive either 30 mg or 60 mg of zetomipzomib or a placebo weekly for 52 weeks, alongside standard background therapy. 
  • The study will include a required tapering of corticosteroids to 5 mg per day or less over the first 16 weeks. 
  • The primary outcome measure is the proportion of patients achieving a complete renal response (CRR) at Week 37, defined as a urine protein-to-creatinine ratio (UPCR) of 0.5 or less without the use of rescue or prohibited medications.

About Zetomipzomib

  • Zetomipzomib (KZR-616) is a novel, selective immunoproteasome inhibitor with extensive potential across autoimmune diseases. 
  • Preclinical studies indicate that targeting the immunoproteasome produces a broad anti-inflammatory effect in various autoimmune disease models, without general immunosuppression. 
  • Clinical data from Phase 1 and Phase 2 trials suggest that zetomipzomib has a favorable safety and tolerability profile, supporting its development for treating severe, chronic autoimmune conditions.

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